DuraSecure
DESIGN
RESULT
REFERENCES
CONSTRAINTS
Bioabsorbable Materials
Minimally invasive
Scaleable to different procedures
Intuitive to Use
Quicker than suturing
ACKNOWLEDGEMENTS
PROBLEM
Failure of watertight dural closure - Cerebral Spinal Fluid leakage
causing meningitis.
Current techniques take at 15 - 30min to apply.
Closing techniques and materials cost >$750
TEAM MEMBERS:
SPONSOR:
SUPERVISORS:
Pierre Mourad, PhD., Imen Hannachi, PhD., Teddy Johnson
Mark Mayberg, MD
Daryl Hurwitz, Joseph Mertens, Tyler Ginet
INTRODUCTION
During intracranial surgery one of the
most potentially dangerious and time
consuming portions can be repairing
fenestrations (openings) in the dura
mater. Current methods include
suturing the fenestration which is time
consuming, costly to the patient and
potentially dangerous if mishaps occur.
We were tasked with creating a quick
ecient and safe solution to this
problem.
SOLUTION
A quickly deployable device that eliminates sutures and leakage.
Application of device allows for proper seal and can be actuated
roughly 1 minute prep work
0
5
10
15
20
25
30
1
228
455
682
909
1136
1363
1590
1817
2044
2271
2498
2725
2952
3179
3406
3633
3860
4087
4314
4541
4768
4995
5222
5449
5676
5903
Pressure (cmH2O)
Samples
DuraSecure
0
5
10
15
20
25
30
1
93
185
277
369
461
553
645
737
829
921
1013
1105
1197
1289
1381
1473
1565
1657
1749
1841
1933
2025
2117
2209
2301
2393
Pressure (cm H2O)
Samples
Hefty Material
Pressure Chamber
DuraSecure
DESIGN
Pressure Chamber
Simulate proof of concept Closure Devices
Detect low pressure vairances
Record data and export to txt
Vary pressure lengths
Incorportate Intercranial pressure wavefor
Base piece
DuraGen Suturable™ collagen patches
Folded up like origami
Allowed to expand back out to at sheet
Holds CSF back from leaking out
Arms
Made of low density Polylactic-co-glycolic acid (PLGA)
5 “Bobby Pin” style arms arching out from center
Clasps down on exterior of Dura
Holds Basepiece in place so it does not come lose or shift down
Applicator:
Mechanically actuated through reduction gears and racks
Holds the arms back within cylinder
Released through central push rod
Hooked ends for repositioning and removal of device
Applicator
FUTURE WORK
At this point we have demonstrated proof of concept, where a purely
mechanically actuated device would effectively reduce leakage and hold
pressure up to 25 cm H2O. We also demonstrated an application where
the device is deployed from the applicator on to the fenestration site.
Due to material constraints we were not able to combine these two
concepts into one. Moving forward we will utilize PLGA (polylactic-co-gly-
colic acid) as the material for deployable arms or a cologen matrix
similar to the base at a higher density. The PLGA is a bio-absorbable
material approved by the FDA for human use in dura injury applciation.
The material properties make it an excellent choice as it is exible,
durable, and resilient under these conditions.
Test Chamber: Simulated intercranial pressure (ICP) utilizing the
pressure chamber and a sythetic membrane in place of dura mater.
Increasing pressure from 9 cm of H2O (the minimum normal human
ICP) to pathologic levels (>20 cm H2O).
Pig Studies: In order to determine the ecacy of the design, testing
would need to be carried out on dura matter. Swine and bovine dura
mater closely resembles human dura. Once extracted SEM and
qualitative test were conducted to choose a synthetic material with
material characteristics similar to dura.
Design held pressure at 9 cm H2O (standard ICP).
Held consistent pressure increments of 2 cm H2O every 10 second
interval up to 25 CM H2O (High end ICP).
Withstood pressure at 25 cm H2O for 2 minutes.
Maintained composure of uctuate pressure
Proof of concept was successful, allowing future iteration to applied
on organic material.
ANALYSIS
EXPERIMENTS
APPLICATION
{
2 min
• Debas, H. T., P. Donkor, A. Gawande, D. T. Jamison, M. E. Kruk, and C. N. Mock, editors. 2015. Essential Surgery. Disease Control Priorities, third edition, volume 1. Washing-
ton, DC: World
• DuraGen Suturable, 2006. Integra LifeSciences Corporation
• D. Chauvet, V. Tran, G. Mutlu, B. George, and J.-M. Allain, “Study of dural suture watertightness: an in vitro comparison of different sealants,” Acta Neurochirurgica, vol. 153,
no. 12, pp. 2465–2472, Dec. 2011.
Troy Dunmier, John Bridge, PhD., Francesco Deleco, PhD., Jong Yoon, PhD.